Lykos Therapeutics

Today, we announce our decision to reorganize Lykos Therapeutics in effort to focus on addressing FDA’s recent decision on our investigational treatment option for adults with PTSD. Learn more here: https://news.lykospbc.com/2024-08-15-Lykos-Therapeutics-Announces-Reorganization-to-Address-FDAs-Recent-Decision-on-Midomafetamine-Capsules-for-PTSD

Thank youAmerican Psychological Association, for hosting another educational and collaborative event! We were thrilled to connect with everyone and share more about our mission to help adults living with .

We remain steadfast in our commitment to working with the FDA to bring this potential new therapy to patients. Read our full announcement here: https://news.lykospbc.com/2024-08-09-Lykos-Therapeutics-Announces-Complete-Response-Letter-for-Midomafetamine-Capsules-for-PTSD

In for this year’s ? We’re here too!

Visit our team at booth #315 to learn more about the neurobiology of .

Today, we announce new initiatives and measures for additional oversight for midomafetamine capsules in combination with psychological intervention (“midomafetamine-assisted therapy”) for the treatment of in adults, if approved by the FDA:



- Establishing an independent advisory board

- Working with top behavioral health facilities

- Collaborating with others on training



Learn more about our dedication to patient safety here: https://news.lykospbc.com/2024-08-01-Lykos-Therapeutics-Announces-New-Initiatives-and-Measures-for-Additional-Oversight-for-Midomafetamine-Assisted-Therapy,-if-FDA-Approved

Learn how PTSD is thought to influence the neurobiology of the brain: https://lykospbc.com/research-and-development/post-traumatic-stress-disorder/

This National Minority Mental Health Awareness Month, learn more about , a serious mental health condition, here: https://bit.ly/4aAg7vA

It’s time to address the unmet need for people living with post-traumatic stress disorder ( ); who may be impacted in all aspects of their lives, from strained personal relationships to impact on their ability to work.

Find more PTSD information and resources from NAMI here: https://bit.ly/4buZAtK

Common post-traumatic stress disorder ( ) symptoms may include avoidance, reoccurring distressing memories, changes in activity level and mood.

Learn more about PTSD symptoms here: https://lykospbc.com/research-and-development/post-traumatic-stress-disorder/

This we recognize those who serve and fight bravely to uphold our freedoms, especially the many who combat every day. Thank you for your service.

It’s common for those living with to feel triggered during celebrations. Many may have strong reactions to fireworks due to the loud noises and flashing lights. Find more information and resources on how to cope here:

VA.gov | Veterans Affairs Apply for and manage the VA benefits and services you’ve earned as a Veteran, Servicemember, or family member—like health care, disability, education, and more.

With limited treatment options, and no new FDA approved treatments in 25 years, represents a significant unmet treatment need for ~13 million Americans each year.

Read our statement in response to ICER’s Final Evidence Report on our investigational therapy for adults with PTSD here: https://news.lykospbc.com/2024-06-27-Lykos-Statement-Regarding-ICER-Final-Evidence-Report

While anyone can develop post-traumatic stress disorder ( ), certain sociodemographic groups are more likely to experience PTSD, such as the LGBTQ+ community, Native Americans or emergency responders.

This learn more about PTSD here: https://lykospbc.com/research-and-development/post-traumatic-stress-disorder/

We appreciate the profound support and efforts of those who share a mutual commitment to improving outcomes for patients living with .

Currently, our priority is to work with the to address any outstanding questions raised during the recent FDA Advisory Committee meeting and provide information to help inform the decision-making process. Amy Emerson, CEO of Lykos Therapeutics, shares more on our next steps in an open letter here: https://news.lykospbc.com/2024-06-13-Lykos-Therapeutics-Statement-on-FDA-Advisory-Committee-Meeting

can impact anyone.
can impact anyone.
can impact anyone.

Find more PTSD information and resources from NAMI here: https://bit.ly/4buZAtK

We are committed to working alongside the FDA to address outstanding questions to find a path forward ensuring the responsible and careful introduction of our investigational therapy into the healthcare system.

https://news.lykospbc.com/2024-06-04-Lykos-Therapeutics-Provides-Update-on-FDA-Advisory-Committee-Meeting-for-Investigational-MDMA-Assisted-Therapy-for-PTSD

We are pleased to welcome seasoned healthcare finance executive, Scott Giacobello, to our Board of Directors.

Scott is currently CFO at Aadi Bioscience and brings > 25 years of U.S. and global biopharmaceutical industry leadership experience to the role. Scott’s extensive financial and operational expertise is a welcome addition as we plan for the potential launch of our MDMA-assisted therapy if FDA-approved.

Read more about this announcement here: https://news.lykospbc.com/2024-05-30-Lykos-Therapeutics-Appoints-Finance-Veteran-Scott-Giacobello-to-the-Board-of-Directors

women are twice as likely to develop post-traumatic stress disorder ( ) in their lifetime?

Post-traumatic stress disorder ( ) may be more prevalent than you may think; yet many people are often undiagnosed or misdiagnosed, resulting in delayed PTSD diagnosis and treatment intervention.

This learn more about PTSD symptoms here: https://lykospbc.com/research-and-development/post-traumatic-stress-disorder/

What a week! Our team is energized after connecting with the many industry experts at the American Psychiatric Association annual meeting to discuss the latest research and investigational treatment options for patients with .

Thank you to everyone for attending our poster presentation at the ISPOR—The Professional Society for Health Economics and Outcomes Research annual meeting.

Looking forward to next year!

Today, we announced the first FDA Advisory Committee meeting for in 25 years will be held on Tuesday June 4 to review our investigational therapy. Read more on this milestone here: https://news.lykospbc.com/2024-05-06-Lykos-Therapeutics-Announces-FDA-Advisory-Committee-Meeting-to-Review-Investigational-MDMA-Assisted-Therapy-for-PTSD

Lykos announces the expansion of its commercial organization with the hiring of its first Chief Commercial Officer and a Vice President of Market Access. Learn more about this exciting development below.
https://news.lykospbc.com/2024-05-03-Lykos-Therapeutics-Strengthens-Commercial-Organization-with-Key-Hires-as-it-Prepares-for-Potential-Commercial-Launch

Today, we’re pleased to announce the completion of our European Phase 2 study of an investigational treatment option for adults with post-traumatic stress disorder ( ). Learn more: https://news.lykospbc.com/2024-04-24-Lykos-Therapeutics-Announces-Completion-of-European-Phase-2-Study-for-MDMA-Assisted-Therapy-for-PTSD

Our team enjoyed connecting with the leaders and advocated at this year’s Conference to discuss the latest research and investigational treatment options for patients with mental health conditions.

Thank you Anxiety and Depression Association of America - ADAA for hosting another informative and eventful conference.

This , we recognize not only the many women who are living with , but also the researchers, therapists, HCPs, advocates and our employees - all who are working to advance PTSD research and treatment options.

We stand firm in our commitment to not only address misperceptions of PTSD, but also to highlight that women are more often impacted than men by this condition.

https://lykospbc.com/research-and-development/post-traumatic-stress-disorder/

We are proud to announce the FDA acceptance and priority review of our new drug application (NDA) filing for our investigational therapy for post-traumatic stress disorder in adults. Learn more about this exciting milestone: bit.ly/42DhZ4q

Lykos Therapeutics (formerly MAPS Public Benefit Corporation) announced that Plos One has published the first study comparing the effects of investigational MDMA-assisted therapy and therapy with placebo on emotional coping skills and self-experience in adults with severe PTSD. The study explored how changes in self-experience impacted PTSD scores in the Company’s Phase 3, randomized, double-blind placebo-controlled study (MAPP1), previously published in Nature Medicine.

Results showed that compared to therapy with placebo, MDMA-assisted therapy had a statistically significant greater improvement in all self-experience measures such as self-compassion and being in touch with oneself.

https://lykospbc.com/press-releases/lykos-therapeutics-formerly-maps-pbc-announces-publication-examining-the-effects-of-mdma-assisted-therapy-on-emotional-coping-skills-and-self-experience-in-ptsd/

Same commitment, new name! MAPS PBC is now Lykos Therapeutics. Selecting the name Lykos – wolf in Greek – was a purposeful decision made to represent bravery, courage, loyalty and intelligence, all things we embody at our company.

https://lykospbc.com/2024/01/05/maps-public-benefit-corporation-announces-oversubscribed-series-a-financing-and-renames-to-lykos-therapeutics/

The MAPS PBC Medical Affairs team is sponsoring a booth at the American Psychological Association (APA) Annual Meeting 2023 in Washington, DC on August 3-5. Stop by booth #223 to learn more about Post-Traumatic Stress Disorder ( ).